Ensuring Remoxy success

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“Make the World a Be/er Place” Ensuring REMOXY Success Confiden’al Timothy R. Roe 82 Sherry Lane Kensington, CT 06037 (860) 829-6688 Home (860) 518-5571 Cell [email protected] Email www.m2details.com Web

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Transcript of Ensuring Remoxy success

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“Make  the  World  a  Be/er  Place”  

Ensuring  REMOXY  Success  

Confiden'al  

Timothy R. Roe!82 Sherry Lane Kensington, CT 06037

(860) 829-6688 Home (860) 518-5571 Cell [email protected] Email www.m2details.com Web

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Contents  

Objec3ves  and  Limita3ons  

About  the  Launch  Background  Informa3on  

Compe33ve  Look  REMOXY  In  Vivo  

Market  Development  and  Projec3ons  

Strategic  Approach  Research  and  Backup  Slides  

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OBJECTIVES  AND  LIMITATIONS  

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ObjecCves  of  PresentaCon  

•  Thorough  understanding  of  the  marketplace,  REMOXY  and  the  commercial  environment  

•  Depict  ability  to  think  strategically  

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LimitaCons  

•  Only  publically  available  informa3on  was  u3lized  

•  Some  data  could  not  be  adequately  referenced,  thus  valida3on  maybe  suspect.  

•  Some  public  informa3on  maybe  dated  or  inaccurate.  

•  Conclusions  or  plans  based  on  this  work  represents  only  one  strategic  direc3on  and  is  without  the  benefit  of  team  input  (Marke3ng,  Managed  Markets,  Tech  Ops,  Finance,  Medical,  Legal,  Regulatory  and  Compliance,  to  name  a  few).  

•  Time  –  The  deck  is  long.    I  will  breeze  through  some  parts  that  are  well-­‐understood.    Some  slides  are  incomplete  but  the  thought  process  is  present.  

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ABOUT  THE  LAUNCH  

Confiden'al  

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One  Shot  To  Get  It  Right!!  •  The  World  is  Watching…Wai3ng  

•  King  absolutely  needs  this  success  

•  Tireless  pre-­‐launch  effort  •  Address  Unmet  Needs  in  Opioid-­‐

based  Pain  Management  

•  Not  an  incremental  step  toward  abuse-­‐resistance  –  Must  ensure  percep3ons  are  managed  consistently  across  all  channels  and  targeted  segments    

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REMOXY  “Making  the  World  a  Be1er  Place”  

I'm Gonna Make A Change,!For Once In My Life!

It's Gonna Feel Real Good,!Gonna Make A Difference!

Gonna Make It Right . . .!

…I'm Starting With The Man In!

The Mirror!I'm Asking Him To Change!

His Ways!And No Message Could

Have!Been Any Clearer!

If You Wanna Make The World!

A Better Place!(If You Wanna Make The!World A Better Place)!

Take A Look At Yourself, And!

Then Make A Change!

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BACKGROUND  INFORMATION  

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•  Ini6al  Terms    –  Big  upfront  –  $150  million  –  Significant  milestones  –  up  to  $150  million  –  Royal'es  15-­‐20%  –  King  to  fund,  but  PTI  to  control  development  through  Phase  II,  joint  control  through  Phase  III  

•  Complica6ons    –  PTI  license  to  Durect  Technology  

•  King  to  meet  all  PTI  obliga'ons  to  Durect  (due  diligence,  etc.)    

–  Ini'al  Legal  Hurdles  •  Limited  to  Durect  technology  applied  to  certain  opioids    •  Possible  compe''on  from  other  Pain  (non-­‐Durect)  products    •  Considered  limited  “Right  of  First  Offer”  

•  CommercializaCon  Due  Diligence  –  Agreed  on  detailed  ini3al  budget  for  King  –  Couldn’t  agree  on  detailed  full  budget  at  3me  of  signing,  so  agreed  on  minimum  and  maximum  level  

of  spending  over  several  years  with  JDC  to  determine  specifics  

Source:  Wilson  Sonsini  Goodrich  &  Rosa3  Post-­‐Contract  Presenta3on  

(The  Deal)  /  

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Source:  PainBalance.org  (Funded  by  and  data  provided  by  King  Pharmaceu3cals)  

•  Up  to  56  million  American  adults  (28%  of  the  adult  popula3on)  experience  chronic  pain.    –  16  million  experience  low-­‐back  pain  –  48  million  have  arthri3s—a  disease  

associated  with  chronic  pain  –  25  million  have  migraine  pain  –  20  million  have  jaw  and  lower-­‐facial  

pain  –  4  million  have  neuropathic  pain  

•  Many  people  have  lived  with  pain  for  >5  years  and  experience  it  almost  six  days/week  

•  Younger  people  are  as  likely  to  experience  chronic  pain  as  are  older  people  

•  One-­‐third  of  Americans  lose  20  hours  of  sleep  a  month  because  of  pain  

Chronic  Pain  Prevalence  

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Burden  of    Moderate-­‐Severe  Chronic  Pain  

•  Total  U.S.  direct  and  indirect  cost  of  chronic  pain  is  between  $50  &  $90  billion  per  year  –  $4  billion  of  lost  income  and  produc3vity,  as  well  as  healthcare  costs,  associated  with  arthri3s  

pain  –  People  with  headache  pain  spend  $4  billion  on  medica3ons  according  to  a  2007  study  

•  Chronic  pain  is  associated  with  millions  of  days  of  lost  work  –  Chronic  pain  brings  a  burden  of  depression,  anxiety,  frustra3on,  fa3gue,  isola3on,  and  lowered  

self-­‐esteem.    It  shaoers  produc3ve  lives.  

–  “Presenteeism”:  75%  of  the  lost  Produc3vity  is  due  to  Reduced  performance  while  on  the  job  –  not  work  absences.  

–  25%  of  people  in  industrialized  countries  lose  work  because  of  chronic  pain  

–  People  with  low-­‐back  pain  lose  93  million  days  of  work  according  to  a  2007  study  –  People  with  headaches  and  migraine  headaches  lose  157  million  days  of  work  according  to  a  2007  

study  

•  The  American  Board  of  Pain  Medicine  has  taken  the  lead  in  educa3ng  and  creden3aling  pain  medicine  specialists.      –  So  far,  the  board  has  cer3fied  just  1,700  doctors  as  pain  specialists.  That's  about  

one  pain  specialist  for  every  23,500  people  who  need  care.  –  With  specialists  so  rare,  many  pa3ents  are  cared  for  by  doctors  who  lack  training  

and  experience  in  the  appropriate  use  of  pain  therapies.  

Source:  Chronic  Pain  Organiza3on  Web  Site  May  7,  2010    Stewart,  WF  et  al.  JAMA,  2003;290:2443-­‐2454    PainBalance.org  (Funded  by  and  data  provided  by  King  Pharmaceu3cals)   12  

Confiden'al  

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Under-­‐Treatment  •  Only  25%  of  those  suffering  from  chronic  pain  receive  

appropriate  treatment  –  Postopera3ve,  cancer,  and  chronic  pain  are  unlikely  to  be  treated  

adequately  –  Elderly,  children,  minori3es,  and  substance  abusers  are  unlikely  to  

receive  adequate  pain  care  –  Doctor  visits  for  pain-­‐related  illnesses  were  the  primary  reason  for  66.16  

million  visits—7.3%  of  all  visits—in  the  United  States  in  2003  –  Drugs  for  the  relief  of  pain  were  prescribed  during  all  pa3ent  visits  more  

oten  than  any  other  therapeu3c  class  

•  Reasons  for  Under-­‐treatment  –  Failure  of  healthcare  professionals  to  properly  assess  pain    –  Pa3ent  factors  such  as  financial  barriers  and  poor  adherence    –  Mispercep3ons  among  healthcare  professionals  about  the  

consequences  of  opioid  use    –  40%  of  people  with  chronic  non-­‐cancer  pain  are  not  currently  under  a  

healthcare  professional’s  care          

•  Many  non-­‐unified  pain  assessments  and  treatment  algorithms  

Source:  PainBalance.org  (Funded  by  and  data  provided  by  King  Pharmaceu3cals)  

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Percep3on

s  

Supply  

Physician  

Needs  Treatment  

Major  Barriers  to  NarcoCc  Use  •  PaCent  and  Physician  PercepCons  

–  Ease  of  abuse  –  Addic3on  poten3al  –  Concern  of  stereotyping/s3gma  

•  Physician  Issues  (Opiophobia)  –  Rx  matching,  regulatory  scru3ny  –  Abuse  poten3al  –  Subop3mal  knowledge  of  pain  and  poor  

assessment  tools  –  Fear  of  Robbery  –  PCPs  manage  50%  of  all  pa3ents  with  pain  –  Pa3ent  non-­‐compliance  with  script  –  50%  of  pa3ents  found  it  necessary  to  change  

physicians,  primarily  because  of  inadequate  pain  management  

–  Oten  relegated  for  terminally  ill  pa3ents  leaving  less  supply  for  others  

–  Overdose  with  lethal  consequences  •  The  number  of  fatal  poisonings  involving  opioid  

analgesics  more  than  tripled  from  4,000  in  1999  to  13,800  in  2006,  according  to  the  Centers  for  Disease  Control  and  Preven3on  

•  Supply  Issues  –  FDA  

•  Stops  several  manufacturers  from  produc3on  un3l  passing  modern  approval  process  

•  Under  higher  scru3ny  ater  Cox-­‐2  Crisis  –  more  stringent  rules  for  new  and  safer  drug  op3ons  

–  Pharmacy  Boolenecks  •  Blame  distribu3on  issues  

–  Distribu3on  System  •  Security  (Loss  Preven3on  &  Training)  •  Refrigera3on  requirements  •  Short-­‐dated  product  •  Manufacturer  supply  factors  

•  Cost  and  Coverage  –  Manufacturer  Price/Rebate  Structure  –  Independent  Insurance/Payer  Coverage,  

Treatment  Protocols  &  Guidance  and  Tier  Structure  

–  Addi3ve  cost  for  abuse  and  dependency  treatments  

–  Diversion  and  Overseas  Counterfei3ng    

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FiZh  Vital  Sign  

Research  shows  that  when  pa3ent’s  acute  pain  is  managed  around  the  clock  and  the  pain  level  is  kept  from  becoming  severe,  the  total  amount  of  opioid  needed  is  reduced.    

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Pain  is  recognized  as  the  “Fith  Vital  Sign”  by  the  Joint  Commission  on  Accredita3on  of  Healthcare  Organiza3ons,  the  American  Pain  Society,  and  the  Veterans  Health  Administra3on.  

1.  Body  temperature        2.  Pulse  rate  (or  heart  rate)        3.  Blood  pressure        4.  Respiratory  rate  

5.  Pain    

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Failure  to  Adequately    Treat  and  Manage  Chronic  Pain  

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PT  with  Unmanaged  Chronic  Pain  

Seen  by  PCP  or  Specialists  

Majority  Treated  Under  Acute  Pain  Algorithms  

Seen  by  PCP  #2,  3…  Due  To  Non-­‐Relief  

PT  has  difficulty  func3oning  produc3vely,  misses  work,  develops  secondary  depression    

Healthcare  Costs  Rise,  MCO’s  Restrict  Access  

Further  

Modern  Approach:    Neurobehavioral  Model  

Most  Chronic  Pain  cannot  be  treated  like  acute  pain.    It  cannot  be  cured,  it  must  be  managed.  

Chronic  Pain  Presenta3on  PT  

• Assessed  • Ini3al  Treatment  • Managed  

PCP/Spec  

Pain  Under  Control  for  Long-­‐Term  PT  

Gallagher,  RM,  Med  Clin  Noth  Amer,  1999,  83  555-­‐583;  Gallagher,  RM,  AmJ  Phys  Med  Rehab  2005,  B4  (Suppl)  s64-­‐s76  

Tradi3onal  Approach:  

In  a  2008  APS  study,  nearly  50%  of  pa3ents  found  it  necessary  to  change  physicians  at  least  twice,  primarily  because  of  inadequate  pain  management.  

70%  who  received  treatment  con3nued  to  report  pain.  

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Opioids: Advantages and Disadvantages

•  Advantages  –  Effec3ve  against  moderate  to  severe  pain,  

par3cularly  nocicep3ve  pain  

–  No  dose  ceiling  –  No  end-­‐organ  toxicity  

•  Disadvantages  –  Poten3ally  addic3ve  Class  II  controlled  substances  

•  Pose  risk  of  abuse,  misuse,  and  diversion  

–  Dosage  limita3ons  due  to  side  effects—especially  cons3pa3on,  nausea,  and  somnolence—may  be  necessary  

–  Can  cause  respiratory  depression  and  should  be  used  with  cau3on  in  pa3ents  with  impaired  ven3la3on  

Source:  PainBalance.org  (Funded  by  and  data  provided  by  King  Pharmaceu3cals)  

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Confiden'al  

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American  Society  of  Health-­‐System  Pharmacists  (2009-­‐03-­‐23).  "Oxycodone".      U.S.  Na3onal  Library  of  Medicine,  MedlinePlus.  hop://www.nlm.nih.gov/medlineplus/druginfo/meds/a682132.html.  Retrieved  2009-­‐03-­‐27.  

Side  Bar  

Worldwide  Produc3on  Growth  

11.5  tons  in  1998  75.2  tons  in  2007  (U.S.  accounts  for  82%  or  51.6  tons  in  2007)  

That’s  3  trucks  or  1  C-­‐5  Galaxy  

Side-­‐Effects  of  Oxycodone  IM  

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Common  Opiate  Methods  of  Abuse    by  Brand  

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Source:  Budman    et  al.  Harm  Reduc3on  Journal  2009  6:8  

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REMOXY  ADF  

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Crushed  

REMOXY  

Crushed  

OxyCon3n  

No  Rapid  Release    of  Oxycodone   Euphoria  

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REMOXY  Design    

•  ORADUR  Technology  (SABER)  – Gel  cap  sustained  release  – Novel,  long-­‐ac3ng  formula3on  – U3lizes  a  high-­‐viscosity  base  for  controlled  release  of  ac3ve  over  12  to  24  hour  period  

– Less  prone  to  abuse  – Manufactured  by  a  simple  process  using  conven3onal,  scalable  methods  

– Lower  CoGS  than  most  compe33on  yields  higher  profit  margins  

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REMOXY  as  a  Recognized  Name    “Pre-­‐CommercializaCon”  

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COMPETITIVE  LOOK  Current  and  Horizon    

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CompeCCon/OxyConCn  Approval  

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Approved:  April  5,  2010  

•  The  new  formula3on  will  most  likely  result  in  less  abuse  by  inhaling  or  injec3on,  but  it  s3ll  can  be  abused  or  misused  by  inges3ng  larger  doses  than  are  recommended,  the  F.D.A.  said.    

•  With  the  previous  formula3on,  those  intent  on  abusing  the  drug  could  release  high  levels  of  oxycodone  all  at  once  by  tampering  with  the  pills.    

•  “Although  this  new  formula3on  of  OxyCon3n  may  provide  only  an  incremental  advantage  over  the  current  version  of  the  drug,  it  is  s3ll  a  step  in  the  right  direc3on,”  Bob  Rappaport,  the  F.D.A.’s  director  of  the  Division  of  Anesthesia  and  Analgesia  Products,  said  in  a  statement.    

“Hillbilly  Heroin”  

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REMOXY  Needs  a  Respectable  Piece  of  The  Pie  

Confiden'al  

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50M  US  Chronic  Pain  Sufferers  

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CompeCCve  Oxycodone  ERs  in  Development  

Morphine  in  Phase  II,  Oxycodone  in  Phase  I  

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CompeCCve  Oxycodone  ERs  in  Development  

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Egalet  CompeCCve  Deterrent  

Confiden'al  

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Egalet  Compared  to  Others  Including  REMOXY  

Confiden'al  

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CompeCCve  Oxycodone  ERs  in  Development  

INTELLITAB's  delivery  mechanisms  maintain  the  controlled-­‐release  proper3es  of  a  drug  even  if  the  tablet  is  broken,  crushed  or  consumed  with  alcohol.    Addi3onally  if  crushed  and  added  to  water,  alcohol  or  other  solvents,  form  a  solid  matrix  that  will  prevent  intravenous  injec3on  or  insuffla3on  (snor3ng).  

Resists  Typical  Methods  of  Abuse:  •  When  crushed  or  ground  and  taken  orally,  releases  drug  comparably  to  

an  intact  tablet,  and  significantly  less  than  compe3ng  technologies  •  When  crushed  or  ground  and  snorted,  releases  significantly  less  drug  

than  an  intact  tablet,  and  significantly  less  than  compe3ng  technologies  •  When  crushed  or  ground,  cannot  be  injected  •  When  placed  in  alcohol,  will  not  dose  dump  

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Other  ADFs  

•  OxyCon3n  –  oxycodone  CR  (Purdue)  –  Not  permioed  to  market  the  tablet  as  tamper  resistant.  –  New  tablet  will  be  marketed  as  a  switch-­‐out  for  the  old  tablet  

"so  both  will  not  be  sold,”  there  are  no  labeling  changes.  –  Is  marginal  improvement  so  granted  approval.  

•  Acurox  –  oxycodone  IR  (Acura/King)  –  “Among  the  weakest  and  most  fundamentally  flawed  of  the  ADF  

formula3ons  currently  in  development.”  –  ADF  defeated  with  325mg  Aspirin.    Niacin  flushing  will  simply  

drive  pa3ents  to  other  physicians  the  Rx  of  a  non  ADF  IR  agent.  –  Could  get  “Tamper  Resistant”  label  resul3ng  in  a  marginal  

improvement  and  be  approved  –  Will  add  several  years  to  development  3meline.    Company  only  

has  $33  million  cash.  

31  Confiden'al  

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Other  ADFs  •  Embeda  –  (King)  •  COL-­‐003  &  COL-­‐172  –  DETERx  Technology  (Collegium)  

•  ATLP-­‐0001  –  Smart/Script  (Atlan3c)  

•  OxyTrex  (PTI)  •  Rexista  (IntelliPharm)  

32  Confiden'al  

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Watch  for  Transdermal  Opioids  

•  Delay  in  onset  of  plasma  levels  

•  Appears  to  be  efficient  route  for  chronic  pain  condi3ons  (Small  Compound  Molecule)  

•  Examples    •  Fentanyl  (Duragesic,  IonSys)  •  Sufentanil  (Endo,  In  Development)  •  Buprenorphine  (Europe,  Australia)  •  Hydromorphone  (Altea,  In  development)  

Confiden'al  

33  

Source:    Pamela  P.  Palmer,  MD    Professor  and  Director,  UCSF  PainCARE        Chief  Medical  Officer,  AcelRx  Pharmaceu3cals,  Inc.  

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REMOXY  IN  VIVO  

Confiden'al  

34  

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REMOXY  IN  VIVO  RESULTS  

Four  robust  in  vivo  studies  have  shown  that  under  certain  physical  and  chemical  challenges  the  controlled-­‐release  formula'on  of  REMOXY  is  not  defeated  and  that  these  challenges  do  not  result  in  a  rapid  release  or  dose  dumping  of  oxycodone.    

Moreover,  a[er  mechanical  and/or  chemical  manipula'on,  the  rate  of  rise  of  oxycodone  plasma  concentra'ons  from  REMOXY  is  less  and  the  Tmax  is  longer  than  a[er  an  oral  oxycodone  solu'on  or  OxyCon'n.  The  a]rac'on  of  drugs  such  as  oxycodone  for  abuse  purposes  requires  an  effect  that  is  both  rapid  and  intense.    

The  Abuse  Quo'ent  (AQ),  a  measure  of  a]rac'veness  of  a  formula'on  for  abuse,  for  REMOXY  a[er  physical  and/or  mechanical  manipula'on  remained  far  below  that  of  OxyCon'n  when  manipulated  in  a  similar  manner,  or  a[er  an  immediate  release  oral  solu'on  of  oxycodone.  The5  4  3  2  1  0REMOXY  +4%  EtOH  :  REMOXY  +  Water  REMOXY  +  20%  EtOH  :  REMOXY  +  Water  REMOXY  +  40%  EtOH  :  REMOXY  +  Water0  10  20  30  Subject57  of  60Cmax  Ra'oNDA  22-­‐324  -­‐  REMOXY®  Advisory  Commi]ee  BriefingAvailable  for  Public  Releasecombined  data  from  these  studies  suggest  that  REMOXY  a[er  certain  physical  and  chemical  challenges  may  offer  less  appeal  for  abuse  than  its  comparators.  

35  Confiden'al  

Summary  

(Detailed  Slides  in  Backup  Sec3on)  

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REMOXY  –  Efficacy  Success    in  Phase  III  Trial  

Confiden'al  

36  

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REMOXY  –  Efficacy  Success    in  Phase  III  Trial  

Confiden'al  

37  

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REMOXY:  AnC-­‐Abuse  Crushing  Results  

Confiden'al  

38  

(N  =  10)  

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REMOXY  Pivotal  Phase  III  Study  Design  

Confiden'al  

39  

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REMOXY  In  Vivo  Results  1  

•  PTI-­‐821-­‐CZ  –  The  controlled-­‐release  mechanism  of  the  formula3on  was  not  defeated  ater  crushing  and  extrac3ng  with  40%  ethanol.  

–  Tmax  for  REMOXY  ater  tamper  was  significantly  greater  than  and  twice  as  long  as  that  of  OxyCon3n.  Cmax  

– Although  the  rate  of  absorp3on  was  increased  ater  tamper,  it  remained  well  below  that  of  OxyCon3n  and  for  the  comparator  immediate  release  solu3on.  

40  Confiden'al  

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REMOXY  In  Vivo  Results  2  

•  PTI-­‐821-­‐C04  –  Early  Exposure  (AUC)  to  oxycodone  ater  chewing  REMOXY  was  much  

lower  than  ater  an  oral  solu3on,  suppor3ng  the  premise  that  the  controlled  release  formula3on  was  maintained.  

–  A  decrease  in  Tmax  and  an  increase  in  Cmax  were  observed  ater  rigorous  chewing  of  REMOXY.  However,  the  data  indicated  that  the  controlled-­‐release  mechanism  of  the  REMOXY  formula3on  was  not  defeated,  as  was  evident  from  the  lack  of  dose  dumping  and  plasma  concentra3on  profiles  which  retained  a  broad  plateau,  from  a  Tmax  which  remained  approximately  2.5-­‐fold  longer  than  ater  an  oral  oxycodone  solu3on,  and  a  Cmax  which  was  lower  than  ater  an  oral  solu3on.    

–  The  data  taken  together  demonstrate  that  although  mas3ca3on  of  REMOXY  does  increase  the  rate  of  absorp3on  of  oxycodone  and  peak  exposure  compared  to  REMOXY  swallowed  whole,  it  does  not  approach  that  observed  with  an  immediate  release  oxycodone  oral  solu3on.  

41  Confiden'al  

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REMOXY  In  Vivo  Results  3  

•  PTI-­‐821-­‐CU  – Results  from  this  study  show  that  buccal  administra3on  of  REMOXY  resulted  in  an  increase  in  the  rate  of  oxycodone  exposure,  but  one  that  was  much  lower  than  ater  an  oxycodone  oral  solu3on.    

42  Confiden'al  

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REMOXY  In  Vivo  Results  4  

•  PTI-­‐821-­‐CS  –  Ater  co-­‐inges3on  of  REMOXY  with  ethanol  from  4-­‐40%  the  plasma  concentra3on  profiles  were  similar  to  those  ater  inges3on  with  water  and  con3nued  to  display  typical  controlled  release  proper3es,  consistent  with  maintenance  of  the  controlled-­‐release  characteris3cs  of  the  formula3on  and  without  any  evidence  of  dose  dumping.    

–  There  were  no  significant  effects  on  the  rate  or  extent  of  absorp3on  of  oxycodone  ater  administra3on  of  REMOXY  with  4%  or  20%  ethanol  and  overall  exposure  was  not  affected.    

–  There  was  a  minor  increase  in  Cmax  (10%)  and  exposure  ater  co-­‐inges3on  with  40%  ethanol.  Tmax  was  not  affected  by  co-­‐inges3on  of  REMOXY  with  ethanol  from  4-­‐40%  

43  Confiden'al  

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MARKET  DEVELOPMENT  AND  PROJECTIONS  

Confiden'al  

44  

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Confiden'al  

45  

Opioid  Market  Development  1  Share  Point  =  77  Million  USD  

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Confiden'al   46  

REMOXY  Capture  ProjecCons  

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STRATEGIC  APPROACH…  

Confiden'al  

47  

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48  

Strategy  Under  My  Tutelage:  

The  strategic  plan  must  be    •  Op3mized  

•  From  the  customer’s  perspec3ve  

•  Include  Posi3oning  Analysis  from  “R”  to  “2B”  

•  Non-­‐issues  based  

•  Allow  for  tac3cal  curve-­‐fi}ng  

•  Fully-­‐developed  and  approved  

Strategic Optimization Model PEQ322 � Input Customer Data Here�

Confiden'al  

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49  

OpCmizaCon  

An  op3mized  strategic  plan  is...  •  Simply  a  roadmap.    It  tells  us  where  we  “R”    today  and  where  we  need  “2B”  in  the  minds  

of  our  customers  in  order  to  meet  internal  objec3ves.    It  is  always  an  external  view,  never  internally  focused.      

•  Based  on  customer  (both  Rx’er  and  end-­‐user)  percep3ons  at  3me  points  “R”  and  “2B”  

•  Customer  percep3ons  should  be  measured  across  several  meaningful  aoributes  rela3ve  to  product  profile,  customer  expecta3ons,  and  compe33ve  profiles  –  it  is  that  easy!  

•  Percep3ons  are  80%  reality  (Peter  Drucker  -­‐  modified  Pareto’s  Principle)  

•  Remember  the  marke3ng  adage    form  product  launches  “You  are  not  actually  launched  unless  your  customers  can  recognize  and  tell  you  that  you  are”  

•  Never  issues-­‐based!      An  issues-­‐based  plan  is  never  op3mized.    In  an  op3mized  plan,  issues  are  nothing  more  than  a  bump  in  the  road.    Planning  for  issues  that  may  or  may  never  occur  waste  planning  3me  and  resources.    If  an  issue  is  large-­‐enough  to  be  included  in  the  plan,  then  it  is  not  an  issue,  rather  a  cri3cal  success  factor  to  overcome  

•  Simple  to  understand  and  communicate      

Confiden'al  

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50  

Sample  PercepCon  Analysis…  

Example:  Along  2  Aoributes:  Sa3sfac3on  and  Loyalty   Example:  Along  5  Geographic  Aoributes  

Confiden'al  

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Mapping  Stakeholders  Interests  vs.  REMOXY  Pain  PosiCon  

Confiden'al  

51  

Stakeholders  •  Pa3ents  

–  BID  Pain  Coverage  with  no  breakthrough  pain  

–  Less  side-­‐effects  (no  dose  dumping)  

•  Physicians  –  Safety  (no  dose  dumping)  –  Avoid  diversion  

•  FDA  –  Promotes  general  safety  to  

the  popula3on  •  Payers  

–  Stops  PT  doc-­‐seeking  cycle  thus  reducing  total  medical  costs  

–  Avoid  fraud  and  diversion  

REMOXY  Has  Each  Stakeholder  Covered  

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P.E.S.T.  (PoliCcal,  Economic,  Social,  and  Technological  Analysis)  

•  Should  be  Included  as  part  of  planning  

•  Helps  define  cri3cal  success  pathways  

52  Confiden'al  

The  PEST  factors  can  be  classified  as  opportuni3es  and  threats  in  the  S.W.O.T.  

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S.W.O.T.  -­‐  IniCal  Look  

53  Confiden'al  

•  Controlled  release  mechanism  intact  ater  40%  Ethanol  •  Tmax  Significantly  greater  and  2X  as  long  as  OxyCon3n  •  Rate  of  absorp3on  with  40%  ethanol  id  similar  to  that  of  water  •  High  bioavailability  

•  Slight  rate  of  absorp3on  increase  •  Small  increase  in  Cmax  ater  co-­‐inges3on  with  ethanol  

•  First  true  XRT  oxycodone  to  market  •  Physicians  will  feel  more  comfortable  prescribing  • Managed  Markets  should  provide  coverage  immediately  

•  FDA  –  stability  issues  •  Unmo3vated  or  uninterested  sales  force  

Strengths  

Opp

ortuni3e

s  Weaknesses  

Threats  

Internal  Factors  

External  Factors  

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54  

One  Last  Word  On  Strategy  Development    Most  organiza3ons,  independent  of  industry,  spend  very  liole  resources  on  strategy  development    

•  Brand  Engineers  es3mates  that  less  than  1%  of  budget  dollars  go  toward  strategy  and  posi3oning.  “The  irony  in  this  is  that  these  are  the  marke3ng  aspects  that  ul3mately  drive  the  vast  majority  of  your  spend.  Even  if  you  allocated  2%  or  3%  to  ensuring  appropriate  strategic  and  posi3oning  insight,  would  that  s3ll  be  enough?”  

Ill-­‐Strategic  planning  leads  to  poorly  op3mized  tac3cal  plans  and  can  actually  do  more  harm  over  the  log-­‐term  

•  Example:  Quiznos  Creatures  Campaign  

Bad  Tac3cal  Ideas*:    The  Quiznos  creatures  Superimposed  over  a  Quiznos  sub  shop  were  two  disturbing,  singing  rat-­‐like  creatures.  No  one  wanted  to  eat  in  a  place  associated  with  disease-­‐ridden  rats.    

Fortunately,  the  shop  got  wise  and  ditched  them  ater  public  outcry.  But  it’s  an  image  that  stays  with  you.    Quiznos  is  s3ll  recovering.  

Go  ahead,  look  them  up  on  YouTube–but  don’t  say  you  weren’t  warned.    They  are  all  too  reminiscent  of  the  sort  of  guys  who  hang  outside  a  Quiznos  and  ask  for  your  change!  

*Entrepreneur  Magazine,  Ten  Best  and  Worst  Campaigns  Ever,  January  29,  2009  

Confiden'al  

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55  

“TACDEVEX”  

•  TAC3cal  DEVelopmental  EXercises  are  not  new  concepts  

•  There  are  countless  exercises  to  prepare  a  team  for  posi3ve,  crea3ve  and  enjoyable  tac3cal  planning.    

Confiden'al  

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56  

TacCcal  Curve-­‐Fikng  

•  Will  fast,  inexpensive  “buses”,  or  large,  preoy-­‐to-­‐look-­‐at,  slow-­‐moving  “yachts”  to  take  you  where  you  need  to  go  on  3me?  

•  Not  all  tac3cal  ideas  are  appropriate  just  because    •  everyone  is  doing  it    •  it  has  been  done  this  way  for  years  •  it  is  easy  •  it  is  proven  to  work  

•  This  is  where  team  crea3vity  comes  in...  

Confiden'al  

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57  

Aktude  of  Team  Before  Exercises  

•  Kioen  vs.  Baby  Monkey  A}tude*  •  Kioen  in  Danger  or  Confused  -­‐  meows  and  waits  for  mother  •  Baby  Monkey  -­‐  runs  to  mother,  jumps  on  her  back  and  hangs  on  

for  itself.  •  These  exercises  are  for  monkeys!    

•  Control  Your  “FUDs”  •  Nothing  is  more  harmful  to  posi3ve  crea3ve  a}tude  than  fears,  

uncertain3es  and  doubt  (FUDs).    When  you  are  depressed,  your  thoughts  are  quite  different  from  when  you  are  happy.    When  you  feel  rich  and  successful,  your  thoughts  are  different  from  when  you  feel  poor  and  inhibited.*  

*  Michael  Michalko,  Thinkertoys,  10-­‐Speed  Press,  1991  

Confiden'al  

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58  

Human  Need  for  Consistency  

•  If  thoughts  are  inconsistent  with  other,  stronger  ideas,  then  the  mind  will  reject  them.  

•  Example:  Most  people  immediately  see  only  one  way  to  cut  “13”  in  half.  

*  Michael  Michalko,  Cracking  Crea3vity,p2,  10-­‐Speed  Press,  1991  

Confiden'al  

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Need  a  Partner  in  Sales!!  

Confiden'al  

59  

Find  a  way  to  mo3vate  the  troops  while  op3mizing  the  por�olio.    It  may  translate  into  changes  for  the  beoer.  

Do  we  have  enough  SOV?  

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THANK  YOU!  Together,  we  can  make  the  “World  a  Beoer  Place”  

Confiden'al  

60  

Timothy R. Roe!82 Sherry Lane Kensington, CT 06037

(860) 829-6688 Home (860) 518-5571 Cell [email protected] Email www.m2details.com Web

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RESEARCH  AND  OTHER  BACKUP  SLIDES  

Personal  Research  

61  Confiden'al  

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SEVERE  PAIN  HAS  A  MAJOR  NEGATIVE  IMPACT  ON  EMOTIONAL  WELL-­‐BEING  

WHETHER  OR  NOT  PAIN  IS  UNDER  CONTROL    

Source:    American  Society  Web  Site  May  7,  2010  

Husband  describes  wife’s  pain  as  “almost  being  a  third  person  in  our  marriage”.  

62  Confiden'al  

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SEVERE  PAIN  HAS  A  MAJOR  NEGATIVE  IMPACT  ON  QUALITY  OF  LIFE  

WHETHER  OR  NOT  PAIN  IS  UNDER  CONTROL    

Source:    American  Society  Web  Site  May  7,  2010  63  

Confiden'al  

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Quality  of  Life  Improvement  on  NarcoCc  Pain  Reliever  

THE  QUALITY  OF  LIFE  HAS  IMPROVED  SIGNIFICANTLY  AMONG  THOSE  WHO  HAVE  THEIR  PAIN  UNDER  CONTROL.  

Source:    American  Society  Web  Site  May  7,  2010  64  

Confiden'al  

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EMPLOYERS  ARE  NOT  AS  SUPPORTIVE  AS  CLOSE  FAMILY  AND  FRIENDS  OR  DOCTORS  

Source:    American  Society  Web  Site  May  7,  2010  65  

Confiden'al  

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PercepCon  of  Pain  Relief  by  Drug  Type  

ALMOST  75%  OF  CHRONIC  PAIN  SUFFERERS  PERCEIVE  OTCs  AS  BEING  EFFECTIVE  IN  RELIEVING  MODERATE  TO  SEVERE  PAIN  

A  MAJORITY  ALSO  BELIEVE  NARCOTIC  PAIN  RELIEVERS  AND  Rx  NSAIDS  WOULD  PROVIDE  EFFECTIVE  RELIEF  

Source:    American  Society  Web  Site  May  7,  2010  66  

Confiden'al  

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Current  Pain  Relief  MedicaCon  Usage  

Source:    American  Society  Web  Site  May  7,  2010  

THOSE  WITH  VERY  SEVERE  PAIN  ARE  MORE  LIKELY  TO  USE  ANTI-­‐DEPRESSANTS  AND  ANTI-­‐SEIZURE  DRUGS  

67  Confiden'al  

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OPINION  IS  SPLIT  AMONG  CHRONIC  PAIN  SUFFERERS  BETWEEN  WANTING  TO  TAKE  PILLS  ONLY  WHEN  NEEDED  AND  BEING  ON  A  

REGULAR  SCHEDULE  

ALMOST  ALL  CHRONIC  PAIN  SUFFERERS  TAKE  THEIR  MEDICINE  IN  PILL  FORM;  IT  IS  ALSO  THE  PREFERRED  WAY.  

Source:    American  Society  Web  Site  May  7,  2010  

A  SMALL,  BUT  SIGNIFICANT  NUMBER  OF  CHRONIC  PAIN  SUFFERERS  HAVE  AT  ONE  TIME  OR  ANOTHER  TURNED  TO  ALCOHOL  FOR  RELIEF  

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Severity  of  Pain  for  NarcoCc  Users  

Source:    American  Society  Web  Site  May  7,  2010  

69  Confiden'al  

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NarcoCc  User    -­‐  SCgma  Measurement    AMONG  THOSE  WHO  HEAR  CONCERNS  FROM  OTHERS  IT  IS  LIKELY  TO  BE  A  FAMILY  MEMBER  OR  THEIR  DOCTOR  

Source:    American  Society  Web  Site  May  7,  2010  

70  Confiden'al  

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Risk  EvaluaCon  and  MiCgaCon  Strategy  

Risk  evalua3on  and  mi3ga3on  strategies  (REMS)  formerly  known  as  Risk  Minimiza3on  Ac3on  Plans  (RiskMAPs)  are  a  regulatory  technique  for  dealing  with  an3cipated  risks  of  medica3ons  and  are  especially  important  for  new  drugs  with  abuse  poten3al.  

71  Confiden'al